AMDNCT03843840
Dual Wavelength OCT
An observational study of AMD and Diabetic Retinopathy, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The purpose of this research is the evaluation of a combined coaxial optical coherence tomography (OCT) system to image retina/choroid and to evaluate if post processing of the data can give us insights into property of the tissue imaged. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AMD, Diabetic Retinopathy, Retinal Degeneration
- What is being tested?
- Combined Coaxial Optical Coherence Tomography
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Feb 2019to 21 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with diseased retina
Who may be able to join
- Age>18
- Ability to consent
- Abnormal reflectivity detected in at least one eye in the retina or choroid on OCT testing undertaken as part of routine
- clinical care
Who cannot join
- Media opacities on conventional OCT testing taken on the day of the study visit, that prevents adequate visualisation of
- the retina and/or choroidal substructures in the opinion of the investigator
- Inability to undertake to undertake two additional OCT scans on each eye in addition to their conventional OCT.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Moorfields Eye Hospital NHS Foundation Trust, 162 City Road
London, EC1V 2PD
About this study
Official title: Combined Coaxial Optical Coherence Tomography System to Image the Retina and Choroidal Structures and Estimate Tissue Reflectivity in Healthy and Diseased Retinas
The purpose of this research is the evaluation of a combined coaxial optical coherence tomography (OCT) system to image retina/choroid and to evaluate if post processing of the data can give us insights into property of the tissue imaged.
Read the detailed description
Histology studies have shown that many disorders of the retina and choroid such as age-related macular degeneration is associated with a build up abnormal deposits, in the retina or subretinal space. Being able to detect subtle changes in retina and choroidal structure is crucial for better understanding and monitoring of this potentially blinding condition. This study aims to commercially available Spectralis® OCT-system with a central wavelength of 880nm explore the ability of a confocal scanning laser ophthalmoscope (cSLO) for OCT imaging utilising a modified by the addition of a longer wavelength OCT (1075nm , a wavelength deployed on other commercially available OCT scanners). Other commercially available OCT scanners used longer wavelengths to allow deeper penetration and enhanced visualisation of subretinal tissue but less inner retinal detail. Combing both wavelengths could have the advantage of allowing optimum viualisation of inner and subretinal structures. The ability of the systems to acquire repeatable and good quality images of retinal and choroidal structural detail at matching location and compare the results from the two instruments will be evaluated. In addition processing of the images reflectivity with two different wavelength should give us insight into the nature of any abnormal material.
- Conditions
- AMD, Diabetic Retinopathy, Retinal Degeneration, Retinal Dystrophies
- Being tested
- Combined Coaxial Optical Coherence Tomography
- Medical subject headings
- Diabetic Retinopathy, Retinal Degeneration, Retinal Dystrophies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Coaxial Optical Coherence TomographyDevice
Taking images of the retina with two wavelengths
| Study group | Role | What they receive |
|---|---|---|
| Diseased Retina | Not described Receives: Device: Combined Coaxial Optical Coherence Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test retest reliability
Comparison of device test retest variability with those of standard OCT for measurement of tissue reflectivity.
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start15 Feb 2019
- Primary completion30 Nov 2019
- Study completion21 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843840
- Sponsor's protocol ID
- TUFA1040
- Status last verified
- Apr 2022
- First submitted
- 31 May 2018
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Coaxial Optical Coherence Tomography System to Image the Retina and Choroidal Structures and Estimate Tissue Reflectivity in Healthy and Diseased Retinas
- ClinicalTrials.gov ID
- NCT03843840
- Acronym / sponsor ID
- TUFA1040
- Conditions
- AMD, Diabetic Retinopathy, Retinal Degeneration, Retinal Dystrophies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 21 Oct 2020 (actual)
- First posted
- 18 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is the evaluation of a combined coaxial optical coherence tomography (OCT) system to image retina/choroid and to evaluate if post processing of the data can give us insights into property of the tissue imaged.
Detailed description
Histology studies have shown that many disorders of the retina and choroid such as age-related macular degeneration is associated with a build up abnormal deposits, in the retina or subretinal space. Being able to detect subtle changes in retina and choroidal structure is crucial for better understanding and monitoring of this potentially blinding condition. This study aims to commercially available Spectralis® OCT-system with a central wavelength of 880nm explore the ability of a confocal scanning laser ophthalmoscope (cSLO) for OCT imaging utilising a modified by the addition of a longer wavelength OCT (1075nm , a wavelength deployed on other commercially available OCT scanners). Other commercially available OCT scanners used longer wavelengths to allow deeper penetration and enhanced visualisation of subretinal tissue but less inner retinal detail. Combing both wavelengths could have the advantage of allowing optimum viualisation of inner and subretinal structures. The ability of the systems to acquire repeatable and good quality images of retinal and choroidal structural detail at matching location and compare the results from the two instruments will be evaluated. In addition processing of the images reflectivity with two different wavelength should give us insight into the nature of any abnormal material.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diseased Retina | – | Device: Combined Coaxial Optical Coherence Tomography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with diseased retina
Key inclusion criteria (4 listed)
- Age>18
- Ability to consent
- Abnormal reflectivity detected in at least one eye in the retina or choroid on OCT testing undertaken as part of routine
- clinical care
Key exclusion criteria (3 listed)
- Media opacities on conventional OCT testing taken on the day of the study visit, that prevents adequate visualisation of
- the retina and/or choroidal substructures in the opinion of the investigator
- Inability to undertake to undertake two additional OCT scans on each eye in addition to their conventional OCT.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined Coaxial Optical Coherence TomographyTaking images of the retina with two wavelengths | Device | Diseased Retina |
Primary outcome
Test retest reliability
Time frame: 14 months
Comparison of device test retest variability with those of standard OCT for measurement of tissue reflectivity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AMD and Diabetic Retinopathy, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test retest reliability (time frame: 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.